Lead Medical Director, Product Development, Neuromuscular, Basel

vor 1 Tag

Basel, Schweiz TN Switzerland Vollzeit

Lead Medical Director, Product Development, Neuromuscular, Basel

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Location:

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Job Reference: 5bfe226e7806

Job Views: 8

Posted: 21.01.2025

Expiry Date: 07.03.2025

Job Description:

The Position

Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients.

The Lead Medical Director leads or makes major contributions to development of the Clinical Development (CD) strategy and plan and is responsible for effective and efficient execution for the assigned molecule(s)/indication(s). Lead Medical Directors are expected to perform their responsibilities with more independence by comparison to Medical Directors.

Experience and Required Qualifications:

  1. Board Certified Neurologist with Neuromuscular clinical experience required.
  2. Relevant clinical, scientific, or clinical trial/development experience in same/similar therapeutic area required.
  3. Academic/teaching background is a plus.
  4. Significant experience working with the principles and techniques of data analysis, interpretation, and clinical relevance.
  5. Experience publishing results of a scientific study in a peer-reviewed journal is preferred.
  6. Significant pharma/biotech industry experience OR is a recognized expert in the field.
  7. Significant experience designing and conducting clinical trials.
  8. Experience authoring a global development plan is preferred.
  9. Understanding of Phase II – III drug development.
  10. Knowledge and understanding of Phase I & IV drug development is a plus.
  11. Understanding of product and safety profiles.
  12. Regulatory: Knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, and other relevant guidelines and regulations is required.
  13. Four (4) or more years pharma/biotech industry experience OR is a recognized local expert in the field.
  14. Up to 30% global travel.

Key Skills and Behaviors:

  1. Ethics: Has impeccable ethics. Demonstrates, or proven ability to demonstrate, Roche Values.
  2. Attention to detail: Outstanding attention to detail.
  3. Business Acumen: Has sound knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process.
  4. Organization: Can prioritize multiple tasks and goals on time, on target, and within budget.
  5. Interpersonal skills: Strong interpersonal, verbal communication and influencing skills.
  6. Presentation skills: Strong business presentation skills.
  7. Negotiation Skills: Strong negotiation skills.
  8. Decision Making: Makes good business decisions and exercises sound judgment.
  9. Financial acumen: Proven abilities for effective planning, development, and oversight of project budgets and other resources.
  10. Mentoring: Aptitude or proven ability to mentor colleagues and foster their successful career development.

Specific Duties and Responsibilities:

  1. Leads or makes major contributions to development of the CD plan for assigned molecule(s)/indication(s).
  2. Gathers and analyzes data and information necessary to create the CD plan.
  3. Responsible to ensure strategic and operational alignment of the CD plan with the relevant CD strategy.
  4. Works with other CST members and relevant sub-teams to develop CD plan components.
  5. Stays abreast of internal and external developments, trends, and other dynamics relevant to the work of CD.
  6. Collaborates with a variety of internal and external partners and stakeholders.
  7. Represents CD for the assigned molecule(s)/indication(s) to other internal Roche groups.
  8. Supports internal partners in transitioning new drugs/indications into Medical Affairs studies.
  9. May provide clinical science input into annual and strategic Lifecycle Plans.

Location: Boston, MA (USA), Basel (Switzerland) or Welwyn (UK). Relocation benefits are provided for this position.

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